Parenteral liquid administration set with injection site and method of making same

ABSTRACT

An administration set in the form of a tubular conduit for draining blood, dextrose solutions, et. from a container to a patient&#39;&#39;s vein. This administration set has an improved injection site made of a rubber tube length which has been turned inside out and which has an inner wall surface in a constant state of annular compression. The rubber tube length quickly and tightly reseals a puncture hole made by a needle of a hypodermic syringe used to inject additive medication into the administration set.

WITH INJECTION SITE AND METHOD OF MAKING SAME 8 Claims, 6 Drawing Figs.

U.S. Cl 128/214, 138/103, 138/178 Int. Cl. A61m 5/00 Field ofSearch128/214,

214.2,215,216;138/109,103,118,178;285/235; 251/4; 174/(Inquired) UmtedStates Patent 11113,566,868

[72] inventors Victor II. Baptist [56] References Cited 'f f'm B UNlTEDSTATES PATENTS e mdk'nusAngelescam' 3,108,813 10/1963 Brownetal 277/1 21Appl.No. 755,184

. 2,681,654 6/1954 Ryanetal. 128/214 [22] F11ed Aug.26,1968

2,827,081 3/1958 Little 128/214X Painted 2832338 4/1958 Ryan... 128/214Assgnee Amman 3,447,570 6/1969 COllinS 12s/214x Evanston, Ill.

Primary Examiner-Dalton L. Truluck Att0rney-Larry N. Barger and RobertT. Merrick 1 4] PARENTERAL LIQUID ADMINISTRATION SET ABSTRACT: Anadministration set in the form of a tubular conduit for draining blood,dextrose solutions, etc. from a container to a patients vein. Thisadministration set has an improved injection site made of a rubber tubelength which has been turned inside out and which has an inner wallsurface in a constant state of annular compression. The rubber tubelength quickly and tightly reseals a puncture hole made by a needle of ahypodermic syringe used to inject additive medication into theadministration set.

PATENTED HAR 21971 INVENTORS VlCTOR H. BAPTIST MITCHELL B. BRODKIN 7f ATTORNEY FARENTERAL LIQUID ADMllNiSTRATION SET WETH INJECTEGN SilTlE ANDMETHGD OF MAKING SAME This invention relates to apparatus for infusingparenteral liquids into a patient and more particularly it relates to atubular conduit or administration set which leads from a dispensingbottle or flexible bag to the patient.

in the past, administration sets included a flexible plastic tubeattached to a drip housing for measuring flow rates, which drip housinghad a tubular spike at one end for making connection with aliquid-filled bottle or bag. At an opposite end of the flexible plastictube was a hypodermic needle for insertion into a patients vein. Inbetween ends of the plastic tube were a clamp for regulating flow ratesthrough the tube and an injection site for injecting additionalmedication. The injection site was a short length of rubber tubeconnected in series with the plastic tribe. When a nurse or physicianadded supplemental medication such as vitamins, anesthetics, etc. to theparenteral liquid he injected them into theshort length of rubber tubewith a hypodermic syringe.

These previous rubber tube lengths had definite disadvantage in thatthey would not always reseal a puncture hole made by a needle of thehypodermic syringe. Sometimes-the parenteral liquid would ooze or dripfrom the puncture hole, particularly if the parenteral liquid wasadministered under pressure. This was very undesirable because an outersurface of the rubber tube length was not sterile, having been handledduring insertion of the supplemental medication. Attempts to improve theresealability of the rubber tube length after puncture by increasingitswall thickness made the tube very difficult to puncture with ahypodermic needle.

With our invention we have overcome this disadvantage of previous rubberinjection sites. We .have greatly improved the injection sitesresealability after puncture with a hypodermic needle without increasingits wall thickness. This has been done by providing a tubular rubberinjection site which has an inner wall surface in a constant state ofannular compression. As soon as a hypodermic needle is withdrawn fromthe injection sites wall, the inner wall surface thereof quickly andtightly closes the puncture hole. The inner wall surface of theinjection site is held in a constant state of annular compressionbecause the rubber tube length was everted or turned inside out prior toattaching it to the administration set.

The present invention is shown in two embodiments. The first embodimenthas ends of the everted rubber injection site connected to theadministration set and has an inner wall surface which can come inphysical contact and be wetted by parenteral liquid flowing through theadministration set. This first embodiment is suited for administeringparenteral solutions such as dextrose, saline, etc. and whole bloodwhich are not materially damaged by contact with rubber. The secondembodiment is suited for administering blood platelets. Blood plateletsare very delicate and are sometimes damaged by the vulcanizing andcuring agents used in rubber, but are not so damaged by thermopiasticssuch as polyvinyl chloride. In this second embodiment, the evertedrubber injection site is telescoped over an outer surface of a flexiblethermoplastic tube of the administration set, which thermoplastic tubeprotects the platelets from substantial contact with the rubberinjection site.

These embodiments of the invention are illustrated in the attacheddrawings, in which:

FIG. ll is a front elevational view of a first embodiment of theadministration set showing it attached to a bottle of parenteral liquid;

FIG. 2 is an enlarged cross-sectional view of the injection site of thefirst embodiment of the administration set;

FIG. 3 is an enlarged cross-sectional view of the injection site of asecond embodiment of the administration set;

FIG. 4 is an enlarged cross-sectional view of a rubber tube length inthe process of being everted;

FIG. 5 is a cross-sectional view taken along line 5--5 of FIG. 4 showingthe rubber tubes condition prior to eversion; and

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 2 showingthe rubber tubes condition after eversion.

Referring to these drawings, the first embodiment of the invention isshown in FIGS. 1 and 2. In FIG. 1 the administration set includes anelongated tubular conduit with an outer surface, an inner surface and abore therethrough. This tubular conduit has a hollow spike 1 at itsupper end which is adapted to connect with a parenteral liquid container2, and a drip housing 3 connected to the spike measures liquid flowrates through the administration set. At a bottom end of the driphousing it attached a thermoplastic tube 4 of a material such aspolyvinyl chloride and this thermoplastic tube 4 has a clamp 5 thereonfor adjusting flow rates through the administration set. A pierceable,resealable elastomeric tube length 6 of a material such as rubber hasone end connected to a lower end of the thermoplastic tube 4 and hasanother end connected to adapter 7, as best shown in FIG. 2. The adapter7 in turn has a hypodermic needle 8 attached thereto. With thisarrangement, the administration set as shown in FIG. 1 can drainparenteral liquid from the container 2 through a bore of the hollowassembled conduit and into a patients vein through hypodermic needle 8.

When additional medication is to be supplied to the parenteral liquidbeing administered to the patient, a nurse or physician injects suchmedication into an injection site such as rubber tube length 6 with ahypodermic syringe 9. The rubber tube length 6 which has been evertedquickly and tightly seals the puncture hole made by needle 10 after theneedle is withdrawn. This happens because the rubber tube length 6 hasan inner wall surface 11 which is in a constant state of substantialinternal annular compression.

To measure the remarkably improved resealability brought about by theeverted rubber tube lengths, tests were run comparing them to unevertedrubber tube lengths. These tests involved puncturing each rubber tubelength at an approximately 30L angle to its longitudinal axis with an 18gauge hypodermic needle and subsequently withdrawing the needle. Next,water was put inside the rubber tube lengths and pressure up to 15p.s.i. applied until one drop oozed through the puncture hole in a 10second period. Twenty samples of the everted tubes and 20 samples of theuneverted tube were tested. The everted tubes averaged pressures greaterthan 15 psi. required to causes the tube to leakat the rate of one dropevery 10 seconds. The uneverted tube on the other hand leaked at thesame rate when an average of 4.8 p.s.i. was applied.

To understand how the inner wall surface is maintained in such a stateof internal annular compression, it is helpful to trace through thesteps of how rubber tube length 6 is made. First, the rubber tube lengthis formed by known rubber processes such as dipping an elongated mandrelinto a latex bath and then stripping the tube from the mandrel. The tubelength 6 is then everted as shown in FIG.'4, and the outer wall surface11 now becomes the inner wall surface 11. The crosssectional view ofFIG. 5 shows the rubber tube length before it is everted and its outersurface 11 has been divided into four equal segments by reference dots.The distance between two of the reference dots is indicated by a. FIG. 6shows the rubber tube length after it has been everted and how thereference dots are much closer together as shown by distance b. This iswhy the inner wall surface I! of FIG. 6 is in a state of constantinternal annular compression.

The outer wall surface 12 of the rubber tube length in FIG. 6 is in aconstant state of annular tension because its circumference has beenstretched from its initial inner wall surface circumference. This normaltension in the outer wall surface 12 helps due to inversion keep theinner wall surface ll under compression. A rubber tube which is in astate of eversion relative to the state in which it was formed looksvery much like an uneverted tube. However, if one cuts a small thin ringfrom one end of the everted tube, this ring rolls inside out and goesback to its originally formed uneverted condition.

This same type of everted rubber tube length is used in the secondembodiment of the invention shown in FIG. 3. Here, a

rubber tube length 13 is telescoped over an outer surface of thethermoplastic tube 4 and is held there either by friction or anadhesive. The termoplastic tube 4 prevents the inner wall 14 of therubber tube length from contacting parenteral liquid flowing through theadministration set, except perhaps right at the puncture hole. Theembodiment of FIG. 3 works very well for administering blood plateletsbecause these platelets are sometimes damaged by contact with rubber.

In this application we have used specific embodiments to describe ourinvention. However, it is understood that persons skilled in the art canmake certain modifications to these embodiments without departing fromthe spirit and scope of the invention.

Prior art considered in preparing this application: U.S. Pat. No.3,030,954, Class 128 Subclass 214 Thornton U.S. Pat. No. 3,030,955 Class128 Subclass 272 Gossett et al.

Iclaim:

1. An apparatus for administering parenteral solutions, comprising incombination:

an elongated conduit having one end adapted to be connected to a liquidto be administered and other end adapted for connection means foradministering a parenteral solution to a patient; and a pierceable,elastomeric tube communicating with said conduit for permittingadditives to be medically administered into said conduit, theimprovement in which said elastomeric tube has an inner wall surfacesubstantially in the constant state of annular radial compressionwhereby a puncture hole produced by a hypodermic needle or the like istightly closed and substantially sealed due to the internal annularradial compression at said inner wall surface where the needlepenetrated the wall of said elastomeric tube adjacent the outer surfaceis-in a constant state of annular tension.

2. The structure as claimed in claim 1 in which the wall of saidelastomeric tube is everted.

3. The structure as claimed in claim 1 in which said elastomeric tube isa one piece element and includes an inner surface in directcommunication with conduit for direct communication with the parenteralfluid being administered.

4. The structure as claimed in claim 1 in which said conduit is of athermoplastic material and the elastomeric tube length is telescopicallyengaged over the outer surface of said tube, the thermoplastic conduitsubstantially preventing the parenteral fluid from contacting the innersurface of said elastomeric tube length whereby blood platelets can bereadily administered.

5. The structure as claimed in claim 1 in which said elastomeric tube isrubber.

6. The structure as claimed in claim 1 in which said conduit comprisesflexible polyvinyl chloride material.

7. A method of forming a parenteral liquid administration set with aninjection site, said method comprising the steps of: forming athermoplastic tubular conduit with a bore for carrying parenteralliquids; forming a length of pierceable, resealable, elastomeric tube;everting said elastomeric tube length so that its outer wall surfacebecomes its inner wall surface defining a bore, said inner wall surfacebeing in a constant state of annular radial compression and said outerwall being in a constant state of annular tension; and attaching saideverted elastomeric tube length to the thermoplastic tubular conduit,whereby additive medication can be injected through outer and inner wallsurfaces of the everted elastomeric tube length and into its bore.

8. A method of forming a parential liquid administration set as setforth in claim 7 wherein the method includes the step of telescoping theeverted elastomeric tube over the thermoplastic tubular conduit, wherebythe thermoplastic conduit extends completely through the evertedelastomeric tube's bore.

2. The structure as claimed in claim 1 in which the wall of saidelastomeric tube is everted.
 3. The structure as claimed in claim 1 inwhich said elastomeric tube is a one piece element and includes an innersurface in direct communication with conduit for direct communicationwith the parenteral fluid being administered.
 4. The structure asclaimed in claim 1 in which said conduit is of a thermoplastic materialand the elastomeric tube length is telescopically engaged over the outersurface of said tube, the thermoplastic conduit substantially preventingthe parenteral fluid from contacting the inner surface of saidelastomeric tube length whereby blood platelets can be readilyadministered.
 5. The structure as claimed in claim 1 in which saidelastomeric tube is rubber.
 6. The structure as claimed in claim 1 inwhich said conduit comprises flexible polyvinyl chloride material.
 7. Amethod of forming a parenteral liquid administration set with aninjection site, said method comprising the steps of: forming athermoplastic tubular conduit with a bore for carrying parenteralliquids; forming a length of pierceable, resealable, elastomeric tube;everting said elastomeric tube length so that its outer wall surfacebecomes its inner wall surface defining a bore, said inner wall surfacebeing in a constant state of annular radial compression and said outerwall being in a constant state of annular tension; and attaching saideverted elastomeric tube length to the thermoplastic tubular conduit,whereby additive medication can be injected through outer and inner wallsurfaces of the everted elastomeric tube length and into its bore.
 8. Amethod of forming a parential liquid administration set as set forth inclaim 7 wherein the method includes the step of telescoping the evertedelastomeric tube over the thermoplastic tubular conduit, whereby thethermoplastic conduit extends completely through the everted elastomerictube''s bore.